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M Vina-Baltsas asked about Revision control for Ops manuals for medical devices. "We use revision control for our manuals but we do not indicate anywhere in the manual which version of the software the manual relates to. So, when a client calls our Service department ...for...an additional manual, we don't know which manual to send them because that history is not maintained anywhere in the manual. How do the rest of you manage this?
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Michelle:
When I worked for any company that manufactured equipment or sold equipment containing assembled hardware and software (from smoke detectors to cable TV systems) the product identification that each manual applied to was a prominent part of each manual's title and/or identification. If it was not incorporated into the manual title, a subheading or information block on the cover and/or title page prominently identified the system and software the manual covered. For example, a boxed area would say "This manual applies to system SR-20, Release 3.0, and software versions 3.01 through 3.1.0."
When PDF copies of the manuals were available for download from the company's website, the list was organized by product type and model number, with the appropriate installation, configuration, administrator, and user manuals for each product listed under each model heading, even if one manual was used for several models.
The more self-evident the manuals and the manual sources are about what applies to what, the happier your customers and your support people will be. And where medical devices are concerned, the better protected your company will be from lawsuits caused by someone not using the correct manual and instructions for any specific device.
Margaret Cekis, Johns Creek GA
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